FDA product code KKO: Ring, Teething, Fluid-Filled
KKO is the FDA product code for ring, teething, fluid-filled. It is a Class II device, regulated under 21 CFR 872.5550 and reviewed by the Dental panel. FDA has cleared 27 510(k) submissions under KKO, from 24 different applicants. The average 510(k) review took 176 days (median 147). FDA has posted 9 recalls for KKO devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Ring, Teething, Fluid-Filled |
| Device class | Class II |
| Regulation | 21 CFR 872.5550 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Top KKO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kids II | 2 | 2011-01-27 |
| Mam International AG | 2 | 2010-07-27 |
| Fu Hong Industries , Ltd. | 2 | 2010-01-21 |
| Solid Toys Ind. , Ltd. | 1 | 2013-05-24 |
| Bebe Toys Manufactory , Ltd. | 1 | 2011-12-02 |
19 more applicants have KKO clearances. See the full list in Caduvo.
Most recent KKO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K123855 | Solid Toys Ind. , Ltd. | WATER-FILLED TEETHER | 2013-05-24 | 161 |
| K110615 | Bebe Toys Manufactory , Ltd. | WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE | 2011-12-02 | 274 |
| K092025 | Kids II | FLUID FILLED TEETHER - GEL | 2011-01-27 | 570 |
| K093266 | Mam International AG | MAM COOLER | 2010-07-27 | 281 |
| K092781 | Mam International AG | MAM TWISTER | 2010-06-23 | 286 |
Recalls for KKO devices
9 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-12-02.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code KKO?
KKO is the FDA product code for ring, teething, fluid-filled. It is a Class II device, regulated under 21 CFR 872.5550 and reviewed by the Dental panel.
What device class is KKO?
Class II, regulation 21 CFR 872.5550. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KKO?
Across 27 cleared submissions the average was 176 days from receipt to decision (median 147).
Which companies have the most KKO clearances?
Kids II (2); Mam International AG (2); Fu Hong Industries , Ltd. (2); Solid Toys Ind. , Ltd. (1); Bebe Toys Manufactory , Ltd. (1).
Have KKO devices been recalled?
Yes: 9 product recalls across 4 recall events; the most recent began 2022-12-02.
Next steps
- Run an FDA pathway report with predicate devices for product code KKO
- Run a recall and safety report across every KKO manufacturer
- Watch product code KKO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.